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Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT05680350
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
16.5
Actual Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study targets to evaluate the role of estimation of plasma expression levels of gene of microRNAs 203 and 210 in helping to diagnose and grade endometriosis. The study included women with unexplained infertility and clinical picture suggestive of presence of endometriosis were divided randomly into two groups: Control and study groups. All patients underwent exploratory laparotomy for diagnosis and grading of endometriosis if present. Patients of study group gave blood samples for estimation of plasma expression levels of microRNA 203 and 210 using qRT-PCR procedure.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic Exploration
  • Diagnostic Test: Estimation of Plasma Expression level of MICRO RNA 203 & 210
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
Plasma Levels of Micro RNA 203 and 210 Might Spare the Exploratory Laparoscopy in Case of un Explained Infertility With Suspected Endometriosis
Actual Study Start Date :
Nov 7, 2020
Actual Primary Completion Date :
Nov 12, 2021
Actual Study Completion Date :
Mar 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Study group

Study group Patients with unexplained infertility had estimated their Plasma Expression level for Gene"Micro RNA "203 & 210" by qRT-PCR followed by laparoscopic exploration

Procedure: Laparoscopic Exploration
Laparoscopic Exploration to diagnose & grade endometriosis

Diagnostic Test: Estimation of Plasma Expression level of MICRO RNA 203 & 210
estimation of Plasma Expression level for Gene"Micro RNA "203 & 210" by qRT-PCR
Active Comparator: Control Group

Control group Patients with unexplained infertility underwent laparoscopy only

Procedure: Laparoscopic Exploration
Laparoscopic Exploration to diagnose & grade endometriosis

Outcome Measures

Primary Outcome Measures

  1. grading of endometriosis [8 months]

    The diagnostic performance of estimated plasma levels of microRNA for diagnosis and grading endometriosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 30-45 years old

  • Unexplained infertility

Exclusion Criteria:

  • Presence of other causes of infertility,

  • age out of the predetermined range,

  • the presence of immune disorders,

  • maintenance on immunosuppressive drugs

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banha University Banhā El- Qalyobia Egypt 13511

Sponsors and Collaborators

  • Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Sharaf Eldein, Assistant professor of gynecology, Benha University
ClinicalTrials.gov Identifier:
NCT05680350
Other Study ID Numbers:
  • RC 2.6.2022
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility
Endometriosis

Study Results

No Results Posted as of Jan 11, 2023